Kornimate/medical-research-clean huggingface dataset:
coolsculpting of the distal thigh study

Conditions: Body Fat Disorder

Summary: evaluate the safety and efficacy of the zeltiq coolsculpting system using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.

this study will investigate the use of a small area applicator with the coolsculpting device for reducing subcutaneous fat in the distal thigh. the study will evaluate the safety and effectiveness of treatments.

Eligibility criteria:
inclusion criteria: * male or female subjects \> 22 years of age and \< 65 years of age. * subject has clearly visible fat on the distal thigh, which in the investigator's opinion, may benefit from the treatment. * subject has not had weight change exceeding 10 pounds in the preceding month. * subject with body mass index (bmi) up to 30. bmi is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. * subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study. * subject has read and signed a written informed consent form. exclusion criteria: * subject has had a surgical procedure(s) in the area of intended treatment. * subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. * subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. * subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * subject is taking or has taken diet pills or supplements within the past month. * subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). * subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system * subject is pregnant or intending to become pregnant during the study period (in the next 5 months). * subject is lactating or has been lactating in the past 6 months. * subject is unable or unwilling to comply with the study requirements. * subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
a study of tirzepatide (ly3298176) in adults with type 2 diabetes switching from a glp-1 ra (surpass-switch-2)

Conditions: Type 2 Diabetes; Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (glp-1 ra) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (gip) glp-1 ra agonist in participants with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (t2d) * have an hba1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol) * have a body mass index (bmi) ≥25 kilogram per square meter (kg/m²) at screening * have been on a stable treatment dose of 1 of the listed glp-1 ras for ≥3 months * no treatment with oral antidiabetic medicine (oam) or on stable doses (for at least 3 months before screening) of up to 3 oam. the oam may include metformin, sodium-glucose linked transporter-2 inhibitor (sglt-2i), thiazolidinediones, or α-glucosidase inhibitors. exclusion criteria: * have type 1 diabetes (t1d) * have a clinical history of * proliferative diabetic retinopathy * diabetic maculopathy, or * non-proliferative diabetic retinopathy that requires acute treatment * are at high risk for cardiovascular disease or have a history of * myocardial infarction * percutaneous coronary revascularization procedure * carotid stenting or surgical revascularization * nontraumatic amputation * peripheral vascular procedure * cerebrovascular accident * or hospitalization for congestive heart failure * have new york heart association (nyha) functional classification class iv congestive heart failure * have a history of ketoacidosis or hyperosmolar state or coma * have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
evaluation of the immune response to sars-covid-19 vaccines in haematological patients: prospective single center study

Conditions: Hematologic Diseases

Summary: the main objective of this study is to investigate the humoral immune response to covid-19 vaccines in haematological patients, by testing sars-cov-2 seroconversion

this single-center prospective study will enroll approximately 700 hematologic patients who access to haematological division (san gerardo hospital, monza, italy) in order to perform their routine blood tests to monitor their hematological conditions. evaluation of sars-cov-2 igg specific antibodies will be performed on left-over biological material (serum or plasma) collected during routine blood tests run between 30 and 60 days after the administration of the second vaccine dose. furthermore, in each patient who has failed seroconversion (absence of specific antibodies for circulation), his cellular immune response will be assessed using an additional blood sample collected during routine blood tests. these samples will be collected within 9 months of the completion of the vaccination series and will be used to evaluate the plasma inf-γ release using quantiferon sars-cov-2 test.

Eligibility criteria:
inclusion criteria: * signed and dated ec-approved informed consent * hematological disease defined according to world health organization (who) criteria * female or male, 18 years of age or older * ecog performance status 0-3 * willingness and ability to comply with routine clinical practice and study procedures * regular vaccination against sars-cov-2 according to italian haematological society (sie) guidelines/recommendations (version 2.0, 20 april, 2021). * routine blood test planned between 30 and 60 days after administration of the second vaccine dose according to regular hematological follow up. * routine blood test planned no later than 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies). exclusion criteria: * preventive vaccination against sars-cov-2 not administered according to italian haematological society (sie) guidelines/recommendations (version 2.0, 20 april, 2021) * evidence of previous infection with the sars-cov-2 virus. * routine blood test not planned between 30 and 60 days after administration of the second vaccine dose. * routine blood test not planned within 9 months after the completion of the vaccination series (only in case of absence of circulation specific antibodies).

Keywords: serocoversion covid vaccination cellular immunity sars-cov-2 igg antibodies quantiferon-sars-cov-2 test
pennington generation cohort

Conditions: Obesity Prevention

Summary: the pennington generation cohort is an observational study comprised of louisiana families. families will be assessed at baseline for a variety of traits and behaviors, and then followed up over time to try to understand the role of lifestyle and the environment on the risk of developing obesity and other health outcomes.

pennington biomedical's greaux healthy initiative partners with communities to grow healthier generations by expanding the access and reach of pennington biomedical's evidence-based practices for the prevention and treatment of childhood obesity. as part of greaux healthy, the pennington generation cohort will help evaluate the impact of the program. a sample of up to 1,500 children and adolescents and their families will be recruited from throughout louisiana. an initial physical exam will establish a baseline for each family with respect to lifestyle behaviors, genetics, and body size/composition. this longitudinal cohort will also assess the association between participation in several childhood obesity prevention and treatment programs and subsequent obesity and related health outcomes. members of the longitudinal cohort will be followed in the future through clinical visits, questionnaires, and through optional linkages to electronic medical records and administrative databases such as the national death index, social security death master file, and health registry data.

Eligibility criteria:
inclusion criteria: * children, adolescents, and young adults (birth through age 24 years) and their nuclear family members\* and adults age 25+ who are expectant parents or are trying to conceive * self-reported resident of louisiana * ability to understand instructions and complete all study procedures * able to provide informed consent (adults aged over 18 years) * able to provide assent (children 9 to 17 years) * able to communicate (oral and written) in english exclusion criteria: * discretion of the medical monitor or principal investigator

Keywords: physical activity obesity diet nutrition families
safety and efficacy study of brimonidine/timolol fixed combination in patients with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions


Eligibility criteria:
inclusion criteria: * diagnosis of ocular hypertension or glaucoma * patient requires iop-lowering therapy in both eyes exclusion criteria: * uncontrolled medical conditions * contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
a multicenter prospective research on the treatment of low pole renal calculus by flexible ureteroscope

Conditions: Renal Calculus

Summary: this study centers on the treatment of low pole renal stones by flexible ureteroscope and intends to find the key anatomical parameters using a prospective, randomized multi-center trial design and to make a more appropriate standard for flexible ureteroscopy of low pole renal stones.

with the development of manufacturing technique, new generation of flexible ureteroscopes have great initiative and passive bending capacity and have greatly expanded its application. in our clinical practice, we have found that ipa (infundibulopelvic angle) is no longer a decisive factor for the success of f-urs（flexible ureteroscope） surgeries. thus, we think it is necessary to have further study on the effect of anatomy of renal collecting system for f-urs surgeries.

Eligibility criteria:
inclusion criteria: * • subject has provided informed consent and indicated a willingness to comply with study treatments * subject is 18-70 yrs of age * subject can be either male or female * subject has a diagnosis of low pole renal stones according to ct urography(ctu) or intravenous pyelogram (ivp) results * subject has a single stone 1\~2cm in size (kub), or multiple stones 1\~2cm in cumulative size (kub), and is a surgical candidate for the ureteroscopic approach exclusion criteria: * • subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) * subject has been diagnosed with a urethral stricture or bladder neck contracture * subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks * subject has severe hematuria that might blur the vision of the endoscopy * subject is pregnant or in monthly period * subject has coexistent disease like systemic disease, heart disease, lung disfunction or other diseases that could not tolerate the endoscopic surgery or anesthesia. * subject has unadjusted diabetes or high blood pressure * subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding * subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks) * subject has been diagnosed with hydronephrosis larger than 3cm according to the b-scan ultrasonography examination * subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery

Keywords: lowl pole renal calculus anatomical parameters flexible ureteroscopy
a study of neurovax™, a novel therapeutic tcr peptide vaccine for spms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of neurovax™ vs. incomplete freund's adjuvant ( i f a) placebo. 150 subjects with secondary progressive spms.

the primary objective is to compare between treatment groups the measures of neurologic disability edss scores.

Eligibility criteria:
inclusion criteria: * ages eligible for study: 18 years to 70 years * genders eligible for study: both * accepts healthy volunteers: no criteria * subject is between 18 and 70 years of age, inclusive. * definite ms by the revised mcdonald criteria (2005) (appendix a), with a secondary progressive course. * expanded disability status scale (edss) \>=score 3.5 (appendix b). * two or more documented clinical relapses of ms in the preceding 24 months or one documented clinical relapse of ms in the preceding 1 2 months prior to screening . * laboratory values within the following limits: * creatinine 1 . 5 x high normal. * hemoglobin exclusion criteria: * subjects currently prescribed campath or lemtrada

Keywords: secondary progress multiple sclerosis spms multiple sclerosis neurovax
clinical trial on remote ischemic preconditioning and cerebral small vessel disease

Conditions: Cerebral Small Vessel Disease

Summary: the hypothesis of this study is that remote ischemic preconditioning (ripc) might have a beneficial effect on outcomes of cerebral small vessel disease (csv).

csv constitutes an important type of ischemic stroke due to a generalized hypo-perfusion of brain. few treatment methods are available except some beneficial effect shown with nimodipine. the potential treatment effect of ripc on protection of brain from cerebral small vessel disease has not been investigated. the investigators designed this randomized, double-blind, controlled clinical trial to examine (1) whether ripc has a beneficial effect on brain lesions of csv, and (2) whether ripc can protect patients of csv from cognitive deterioration. there are 2 arms in this trial: one arm is ripc treatment, the other one is sham ripc treatment. brain lesions will be quantified by volumetric mri, and xe-ct will be used to evaluate cerebral blood perfusion. cognitive function will be evaluated by mini-mental state examination (mmse) and the montreal cognitive assessment (moca).

Eligibility criteria:
inclusion criteria: 1. subjects aged 40-80 years; 2. ischemic cerebrovascular event onset, if any, must be within 6 months; 3. tcd and carotid ultrasound exclude vascular narrow that can cause hemodynamic changes (usually \>50% narrow lumen); 4. mri confirmed the presence of lacunar infarction and / or generalized white matter lesions; 5. written consent was obtained from the subject. exclusion criteria: 1. history of intracranial hemorrhage; 2. significant bleeding from other parts of the body; 3. history of atrial fibrillation; 4. history of myocardial infarction within six months; 5. moyamoya disease or vasculitis; 6. hereditary small vessel disorders, such as cadasil, fabry, and mitochondrial encephalo-myopathy; 7. significant bleeding-coagulation dysfunction; 8. abnormal blood pressure, glucose and/or lipids after restrict treatment regimen; 9. severe liver/kidney disease, cancer or critical illness of internal medicine and surgery.

Keywords: remote ischemic preconditioning random-controlled double blind ripc
the feasibility and efficacy of a two-week mct treatment of anxiety disorders in a group setting

Conditions: Anxiety Disorders

Summary: long treatment durations may not always be feasible for patients due to pressure to get better quickly, long travel distance to treatment clinics, inflexible working hours, or childcare. to overcome these challenges intensive treatments are currently emerging and several research studies have shown significant and lasting results of diagnosis-specific intensive treatments. a transdiagnostic treatment in a group setting can contribute to a more efficient course of treatment for patients. research suggests that metacognitive therapy (mct) is an effective treatment for anxiety disorders. however, mct has not previously been used on inpatients over a two-week period. to make the treatment tangible for patients and easy to administer for therapists over a short time, attention training technique (att) will mainly be used as a changing technique. the main aim of the study is to explore the feasibility and efficacy of intensive and short-term mct for anxiety disorders in a group setting.

design: the study will use randomized control trial with a waitlist control. cohorts of 12 included patients will be randomly assigned to active treatment or waitlist for two weeks. the waitlist patients will receive the same treatment immediately after the two-week waiting period. inclusion criteria: adults ranging from 18 to 30 years of age meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia will be included in the study. further the participants must be able to communicate in norwegian and provide written consent. exclusion criteria: exclusion criteria will be ongoing drug abuse, history of psychotic episodes, current suicidality, or participants not able to adapt to an intensive group format.

Eligibility criteria:
inclusion criteria: * adults between 18 and 30 years * meeting diagnostic criteria for generalised anxiety disorder, social phobia, and/or panic disorder with or without agoraphobia * provide written consent to partake in the study exclusion criteria: * ongoing drug abuse * history of psychotic episodes * current suicidality * participants not able to adapt to an intensive group format

Keywords: metacognitive therapy attention training technique
nourishing the community through culinary medicine- acres homes

Conditions: Diabetes; Elevated Body Mass Index

Summary: the purpose of this study is to to implement adapted virtual culinary medicine (cm) curriculum among target population, to assess if program participation improves participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if program participation improves patient levels of hba1c, body mass index, blood pressure, hdl, ldl and triglycerides above standard of care and to determine the feasibility and reproducibility of virtual synchronous cm classes.


Eligibility criteria:
inclusion criteria: * receiving care at ut physicians clinics * diagnosed with type 2 diabetes and elevated body mass index (\>=25) * hba1c labs and clinic-assessed weight completed within the last 3 months; * english speaking or spanish speaking. * can obtain groceries before each class (intervention group only) exclusion criteria: * patients without the technological support needed to participate (e.g., reliable internet and device - cell phone, tablet or laptop); * patients with an uncontrolled impairment that interferes with ability to participate.
developing and piloting an online, self-help intervention (stage) for anxiety

Conditions: Anxiety

Summary: this study pilots a novel, brief, online, self-help training course for anxiety management, aimed at adults experiencing moderate to moderately-severe anxiety.

this study is a pilot randomised controlled trial (rct) comparing a brief, online self-help, anxiety management training course ('stage') with a wait-list control. a battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 3) and at follow-up (week 5).

Eligibility criteria:
inclusion criteria: * having a score, at baseline, on the generalised anxiety disorder 7 (gad-7) scale of between 8 and 15, inclusive; * having regular internet access; * being based in the uk. exclusion criteria: * significant risk issues in the last year; * currently receiving another psychological intervention, whether it be self-help or face-to-face; * having recently (within the last six months) completed a psychological intervention.
ultrasonography of chest versus pulmonary artery ct angiography in patients with symptoms and signs in favor of pte

Conditions: Pulmonary Thromboembolism

Summary: in this study the investigators compare the diagnostic validity of bedside ultrasonography of chest and pulmonary artery ct angiography in the patients who came to emergency department of alzahra general hospital from 1 may 2012 to 1 october 2012 with respiratory symptoms and signs in favor of pulmonary thromboemboli (pte).


Eligibility criteria:
inclusion criteria: * patients with signs or symptoms in favor of pte who come to emergency department of alzahra general hospital. exclusion criteria: * previous history of allergy to iv contrast * serum creatinin more than 1.8 * patients that will not agree to participate in the study. * pregnancy * body weight more than 120 kg

Keywords: pte emergency bedside ultrasonography pulmonary ct angiography pulmonary wedge infarction pulmonary thromboembolism
study on the use of botulinum toxin type a in the treatment of chronic post-stroke spastic patients

Conditions: Spasticity

Summary: the purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with botulinum toxin type a.

as this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. this decision should be made in accordance with routine clinical practice at the hospital concerned. the clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician. this study will not interfere with the routine practice of the investigator or with the patient's treatment plan. assessments will be done only if performed regularly in routine practice. this study will be conducted in brazil, wherein marketing authorization has been granted for the use of bont-a in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.

Eligibility criteria:
inclusion criteria: * time between last documented stroke (either haemorrhagic or ischemic) and study inclusion date equal or longer than 1 year * documented upper limb spasticity, with or without lower limb spasticity * naive to bont-a injections for spasticity treatment * provide written informed consent (signed by the patient or his legal representative) prior to any study-related procedure exclusion criteria: * previous surgical procedure for spasticity treatment, including neurotomy, rhizotomy and intrathecal pump implants * previous phenol injection and/or indication to receive phenol during the study duration * contraindications to any bont-a preparations * patient and/or caregiver unable to comply with the study requirements * the patient has already been included in the study

Keywords: stroke spasticity botulinum toxin type a dysport